A Phase II Study of Immunotherapies (Tiragolumab and Atezolizumab) in Combination With Stereotactic Body Radiation Radiotherapy in Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC)

Background:
Metastatic colorectal cancer (mCRC) is cancer that has spread beyond the colon and rectum. Most people with mCRC die within 5 years. New immune-based treatments are making progress with some types of colon cancer. But these treatments do little for people with a type of cancer that is microsatellite stable (MSS). MSS is a specific cancer biomarker. Better treatments are needed.
Objective:
To test 2 drugs (tiragolumab and atezolizumab) combined with radiation therapy in people with MSS mCRC.
Eligibility:
People aged 18 years and older with MSS mCRC.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and a test of their heart function. They will provide a tissue sample from their tumor; if one is not already available, a new sample will be taken. Their ability to perform normal tasks will be assessed.
Tiragolumab and atezolizumab are both administered through a tube attached to a needle inserted into a vein. Participants will receive both drugs on day 1 of 3-week treatment cycles. Each study visit should last about 8 hours.
Participants will receive radiation therapy on days 1, 3, and 5 of cycle 1 only.
Blood samples and rectal swabs will be collected on day 1 of every cycle.
Imaging scans will be repeated every 9 weeks. Additional tumor samples may be taken during treatment.
Treatment will continue for up to 2 years.
Participants will have a follow-up visit 1 month after treatment ends. Follow-up visits will continue every 3 months for 1 more year.

开始日期2025-08-15

申办/合作机构

National Cancer Institute

NCT07038915

/ Withdrawn临床2期IIT

STRIVE: A Single-arm Phase 2 Study on Treatment of Lung Squamous Cell Carcinoma by Tiragolumab Plus Ivonescimab for Patients Who Progressed on Platinum Doublets and Anti-PD-1/PD-L1

To learn if the drug combination of tiragolumab and ivonescimab can help to control LSCC that got worse after standard treatment with platinum doublets and anti-PD-1/PD-L1 therapy.

开始日期2025-07-28

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT06328036

/ Withdrawn临床2期IIT

Phase 2 and Biomarker Trial of Anti-TIGIT and Anti-PDL1 in Patients With Recurrent Glioblastoma

This phase II trial compares the safety, side effects and effectiveness of atezolizumab with tiragolumab to atezolizumab alone in treating patients with glioblastoma that has come back after a period of improvement (recurrent). Glioblastoma is the most common primary brain cancer in adults and despite aggressive treatment, it is nearly always fatal. Currently, there are limited effective treatment options in patients that have recurrence. Immunotherapy has been shown to be effective in other types of cancer and may be an appealing potential treatment option for recurrent glioblastoma. Immunotherapy with monoclonal antibodies, such as atezolizumab and tiragolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Study doctors also want to learn if a tumor infiltrating T lymphocyte (TIL) response is helpful to determine the benefit of the combination of study drugs compared to the usual approach. TILs are a type of immune cell that has moved from the blood into a tumor. TILs can recognize and kill tumor cells. Giving atezolizumab with tiragolumab may be safe, tolerable and/or effective compared to atezolizumab alone in treating patients with recurrent glioblastoma.

开始日期2025-04-30

申办/合作机构

National Cancer Institute

100 项与替瑞利尤单抗相关的临床结果

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100 项与替瑞利尤单抗相关的转化医学

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100 项与替瑞利尤单抗相关的专利（医药）

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项与替瑞利尤单抗相关的文献（医药）

2026-09-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Investigation of excipient-related artifacts observed in the leachables study of tiragolumab by LC-HRMS and GC-MS

Article

作者: Du, Jie ; Zhou, Yuyin ; Pearson, Richard ; Skidmore, Kenneth

Leachables studies of protein formulations are faced with many analytical challenges arising from relatively high levels of complex formulation components. In the stressed sample of the monoclonal antibody drug tiragolumab with the main excipients methionine, histidine, sucrose, and polysorbate, two unknown compounds were detected in the screening for non-volatile leachables by reversed phase (RP) liquid chromatography high-resolution mass spectrometry (LC-HRMS). Unknown 1 was proven to be a gas-phase mass spectral adduct between methionine and the sucrose-derived hexose. Separation of methionine and hexose by hydrophilic interaction chromatography (HILIC) resulted in the disappearance of the unknown peak. It was also observed that non-covalent amino acid-sugar adducts in the gas phase were prevalent in both electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI) modes. Unknown 2 was identified as a Maillard reaction product 1-(3H-imidazo[4,5-c]pyridin-4-yl)ethan-1-one by LC-HRMS and gas chromatography mass spectrometry (GC-MS). The formation mechanism was confirmed by the reaction between histidine and the sucrose-derived methylglyoxal (MGO) under hydrothermal conditions. This study exemplifies false positive leachable results and delves into the chemical reactions and interactions that generated such artifacts.

2026-08-01·CLINICAL IMMUNOLOGY

Fc-enhanced anti-TIGIT antibody 30,278-IgG1 RMD amplifies antitumor immunity through effector cell activation and synergizes with PD-1 blockade

Article

作者: Lin, Yuanjie ; Yang, Limin ; Heng, Wei ; Zhang, Yu

TIGIT is an inhibitory immune checkpoint receptor, and its blockade has shown clinical promise in combination with PD-1 pathway inhibitors. However, whether anti-TIGIT antibodies should engage immune effector functions via Fcγ receptors (FcγRs) remains an open question. We developed 30,278-IgG1 RMD, a novel Fc-enhanced anti-TIGIT antibody, to amplify effector cell activation through FcγR engagement while preserving TIGIT binding and blockade. 30,278-IgG1 RMD was generated by Fc glycoengineering to increase affinity for activating FcγRs. This variant was compared to wild-type IgG1, an Fc-inert IgG4, and tiragolumab in in vitro assays (TIGIT binding/blockade, ADCC, ADCP, Treg depletion, immune cell activation in human PBMCs) and in an hTIGIT/hPD-1 knock-in mouse colon carcinoma model (CT26) combined with PD-1 blockade. 30,278-IgG1 RMD maintained high TIGIT affinity and blockade activity, while exhibiting markedly increased binding to activating FcγRs. It triggered more potent ADCC and ADCP than wild-type or tiragolumab, resulting in efficient depletion of TIGIT⁺ Tregs and activation of NK cells and dendritic cells. In human PBMC assays, the Fc-enhanced antibody augmented T cell activation and cytokine production relative to Fc-silent and wild-type controls. In vivo, 30278-IgG1 RMD plus PD-1 blockade yielded superior tumor control, including complete tumor regressions in some mice, whereas Fc-inert or wild-type anti-TIGIT combinations did not. Fc engineering of an anti-TIGIT antibody substantially improves immune effector engagement and anti-tumor efficacy. Augmenting FcγR interactions alongside checkpoint blockade can potentiate T cell responses and drive tumor regression, underscoring the translational potential of Fc-optimized checkpoint immunotherapies.

2026-04-30·JAMA Oncology

Tiragolumab Plus Atezolizumab and Chemotherapy for Advanced Nonsquamous Non-Small Cell Lung Cancer: The Phase 3 SKYSCRAPER-06 Randomized Clinical Trial.

Article

作者: Patil, Namrata S ; Troutman, Sarah ; Meng, Raymond ; Ozyilkan, Ozgur ; Amin, Reena ; Stahel, Rolf ; Lovly, Christine M ; Zou, Wei ; Wen, Xiaohui ; Li, Qingshan ; Socinski, Mark A ; Lee, Dae Ho ; Garon, Edward B ; Matheny, Christina ; Alatorre-Alexander, Jorge ; Rodriguez-Abreu, Delvys ; Cappuzzo, Federico ; Nishio, Makoto ; Kilickap, Saadettin ; Johnson, Melissa ; Ferreira da Silva, Flavio Augusto

Importance:

Programmed cell death 1 ligand 1/programmed cell death protein 1 inhibitors, with or without chemotherapy, are standard first-line treatment for patients with advanced non-small cell lung cancer (NSCLC); however, survival benefit is limited, and many patients experience disease progression.

Objective:

To evaluate the efficacy and safety of tiragolumab plus atezolizumab plus chemotherapy vs placebo plus pembrolizumab plus chemotherapy in patients with advanced nonsquamous NSCLC.

Design, Setting, and Participants:

SKYSCRAPER-06 was a phase 3 randomized clinical trial that recruited patients with previously untreated, locally advanced unresectable or metastatic NSCLC at 129 sites in 21 countries between December 15, 2020, and September 14, 2023 (data cutoff, April 19, 2024).

Intervention:

Patients were randomized 1:1 to receive either tiragolumab, 600 mg, plus atezolizumab, 1200 mg, plus chemotherapy (pemetrexed, 500 mg/m2, and carboplatin [area under the curve 5], or cisplatin, 75 mg/m2) or placebo plus pembrolizumab, 200 mg, plus chemotherapy via intravenous infusion on day 1 of each 21-day cycle until disease progression, loss of clinical benefit, unacceptable toxic effect, or withdrawal of consent.

Main Outcomes and Measures:

Primary end points were investigator-assessed progression-free survival and overall survival. The safety and tolerability of the study drugs were also evaluated.

Results:

Of 542 patients in the full analysis set (mean [SD] age, 63.6 [9.3] years; 353 [65.1%] male), 269 were randomized to tiragolumab plus atezolizumab plus chemotherapy and 273 to placebo plus pembrolizumab plus chemotherapy. Overall, baseline demographics were similar between treatment groups. At data cutoff (median follow-up, 11.8 months), median investigator-assessed progression-free survival was 8.3 months (95% CI, 7.1-9.6 months) with tiragolumab plus atezolizumab plus chemotherapy vs 9.9 months (95% CI, 8.7-11.9 months) with placebo plus pembrolizumab plus chemotherapy (hazard ratio, 1.27; 95% CI, 1.02-1.57; P = .99); median overall survival was 18.9 months (95% CI, 15.2-23.8 months) vs 23.1 months (95% CI, 20.7-33.0 months) in each treatment group, respectively (hazard ratio, 1.33; 95% CI, 1.02-1.73; P = .98). Grade 3 to 4 adverse events occurred in 164 of 267 patients (61.4%) in the tiragolumab plus atezolizumab plus chemotherapy group and 165 of 272 patients (60.7%) in the placebo plus pembrolizumab plus chemotherapy group, with grade 5 AEs occurring in 27 of 267 patients (10.1%) and 16 of 272 patients (5.9%) in each group, respectively.

Conclusions and Relevance:

In the phase 3 SKYSCRAPER-06 randomized clinical trial, the primary end points were not met and the study has been terminated.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04619797.

431

项与替瑞利尤单抗相关的新闻（医药）

2026-06-12

·chugai-pharm.co.jp

Tecentriq Filed for Additional Indication as Maintenance Therapy Following Definitive Chemoradiotherapy in Locally Advanced Esophageal Cancer

If approved, Tecentriq is expected to become the first immune checkpoint inhibitor for maintenance therapy in patients with locally advanced esophageal cancer whose disease has not progressed following definitive chemoradiotherapy Filing based on results from the global Phase III clinical trial (SKYSCRAPER-07) TOKYO, June 12, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that it has filed a regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq® Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] for an additional indication as maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer. “There is no established standard treatment for maintenance therapy following definitive chemoradiotherapy for locally advanced esophageal cancer. In the SKYSCRAPER-07 study, Tecentriq monotherapy indicated a trend toward improvement in overall survival and progression-free survival compared with placebo. We will continue our efforts toward obtaining approval so that Tecentriq can be delivered to patients as a new therapeutic option as soon as possible,” said Chugai’s President and CEO, Dr. Osamu Okuda. This filing is based on the results from the global Phase III clinical study (SKYSCRAPER-07/ YO42137)1 in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study is a randomized, double-blind, multicenter trial comparing the efficacy and safety of maintenance therapy with Tecentriq in combination with tiragolumab (development discontinued) or Tecentriq monotherapy versus placebo. Based on the results from the first 2 and second interim analyses, it was confirmed that the Tecentriq monotherapy arm continued to show clinical benefit in the primary endpoint of overall survival (OS) and the secondary endpoint of investigator-assessed progression-free survival (PFS). The results of the second interim analysis are planned to be presented at an upcoming medical congress. The safety profile was consistent with the known safety profile of Tecentriq, and no new safety signals were identified. Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals. About the SKYSCRAPER-07 (YO42137) study1SKYSCRAPER-07 is a global Phase III randomized, double-blind, multicenter study in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study evaluated the efficacy and safety of Tecentriq plus tiragolumab or Tecentriq monotherapy compared with placebo. Development of the Tecentriq plus tiragolumab combination was discontinued as no clinical benefit was observed in the primary PFS analysis and the first interim OS analysis (cutoff: February 18, 2025)2. About maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer3Esophageal cancer has an incidence rate in Japan (2021) of 34.7 per 100,000 population for men and 7.7 per 100,000 population for women. The number of deaths from esophageal cancer in 2024 was 10,638, and the 5-year relative survival rate (2009–2011) was 41.5%. In Japan, squamous cell carcinoma is the most common histologic type. In unresectable, locally advanced esophageal squamous cell carcinoma, there is no clearly established standard treatment for patients without disease progression after definitive chemoradiotherapy, and new treatment options are needed. About Tecentriq4Tecentriq is an immune checkpoint inhibitor designed to target PD-L1 (programmed death-ligand 1) expressed on tumor cells or tumor-infiltrating immune cells. PD-L1 binds to PD-1 and B7.1 receptors on T cells and suppresses T-cell function. By inhibiting this interaction, Tecentriq is considered to restore T-cell activity and promote immune response against tumor cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 7 tumor types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, extranodal natural killer/T-cell lymphoma nasal type, and thymic carcinoma). Trademarks used or mentioned in this release are protected by law. Sources:

临床结果临床3期免疫疗法上市批准

2026-06-11

·拓展生命无限可能

【II/III期临床试验】圣和药业PD-L1/TIGIT双抗新药SH006注射液联合贝伐珠单抗和化疗招募免疫治疗后进展的晚期肝细胞癌患者！

#肝癌经治临床试验简要入排本临床药物为TIGIT/PD-L1双特异性抗体；目前招募晚期肝细胞癌（HCC）患者；年龄：18~75岁；巴塞罗那临床肝癌（BCLC）分期为C期，不适合根治性手术治和/或局部治疗的B期；既往接受过一种含免疫检查点抑制剂药物治疗后失败；排除既往经组织学确诊为肝内胆管癌（ICC）、混合型肝细胞癌-胆管癌（cHCC-CCA）、纤维层状肝细胞癌、肉瘤样肝细胞癌；或诊断为弥漫性肝癌的患者；排除门静脉癌栓累及门脉主干，或同时累及主干和肠系膜上静脉，下腔静脉癌栓；排除既往治疗中曾使用过抗TIGIT药物（Tiragolumab、Rilvegostomig、Vibostolimab等）治疗者；排除既往接受过同种异体干细胞移植或实质性器官移植的患者；脑转移患者需治疗后稳定4周以上；全国多中心。研究中心上海山东临沂、烟台浙江宁波、杭州江西赣州、南昌广东广州、茂名、湛江山西运城福建福州、泉州四川广元、宜宾、内江湖北宜昌、武汉、恩施河南南阳、安阳、郑州安徽阜阳江苏南通、南京辽宁沈阳重庆贵州遵义、贵阳吉林延边湖南长沙广西南宁河北廊坊、石家庄具体启动情况以后期咨询为准【研究中心若有更新请拉至文末查看】试验名称 SH006注射液联合用药对比瑞戈非尼治疗晚期肝细胞癌的前瞻性、随机、阳性药平行对照、开放标签、全国多中心II/III期注册性临床研究。试验药物 SH006注射液为南京圣和药业股份有限公司独立开发、具有自主知识产权的生物制品I类新药，是一款靶向TIGIT和PD-L1的双特异性抗体。TIGIT全称为T细胞免疫球蛋白和ITIM结构域蛋白，是一种主要表达于NK细胞和T细胞表面的抑制性信号分子，阻断TIGIT与其配体CD155的结合，可以使NK细胞发挥对肿瘤细胞的杀伤作用，破坏肿瘤的免疫逃逸机制。与此同时，NK细胞对T细胞的肿瘤杀伤能力有促进作用，TIGIT抑制剂与PD-1/PD-L1类抑制剂联用可以协同激活T细胞，增加具有干细胞特征的记忆T细胞的数目，从而产生更多的效应T细胞，达到更好的肿瘤杀伤效果。 SH006联合用药的I期试验结果显示，联合用药安全性耐受性较好，剂量递增阶段所有剂量组均未发生剂量限制性毒性；同时在已入组的晚期肝细胞癌患者中，表现出较好疗效，展现出令人期待的临床治疗潜力。研究药物：SH006注射液联合用药（II/III期）登记号：CTR20260323 试验类型：对照试验（VS 瑞戈非尼）适应症：晚期肝细胞癌（二线）申办方：南京圣和药业股份有限公司延伸阅读南京圣和药业股份有限公司始建于1996年，是一家集新药研发、药品生产和自主学术推广为一体的国家重点高新技术企业，公司总部位于长江之滨的六朝古都南京，公司现有员工近两千人，其中具有大学以上学历的员工占91%以上，博士、硕士数百人，企业从事创新药研发的专业科研人员400余人。备注：以上信息来源于药企官网注：上下滑动可查看全部内容用药周期 SH006注射液的规格：100mg（5mL）/瓶；用法用量：15mg/kg，静脉滴注；用药时程：Q3W。贝伐珠单抗注射液的规格：100mg（4mL）/瓶；用法用量：15mg/kg，静脉滴注；用药时程：Q3W。奥沙利铂注射液的规格：50mg（10mL）/瓶；用法用量：85mg/m2，静脉滴注；用药时程：Q3W。卡培他滨片的规格：150mg/片；用法用量：1000mg/m2，口服，每日2次；用药时程：给药14天，停7天。对照药物如下：瑞戈非尼片的规格：40mg/片；用法用量：160mg，口服；用药时程：给药21天，停7天。更多项目信息请参考： http://www.chinadrugtrials.org.cn/index.html 温馨提示：文章入排信息来源于国家临床试验官网公示信息，具体情况以实际咨询为准！报名方式参与临床试验，获取国际前沿新药新疗法使用机会！更有一线专家团队为你的治疗保驾护航！【印塔健康】目前有肺癌、肝癌、肾癌、胃癌、肠癌、胰腺癌、妇瘤、泌尿肿瘤、血液肿瘤......等几乎涵盖所有癌种的临床试验正在招募患者！扫描下方二维码添加医学运营一对一咨询或点击左下角“阅读原文”直接报名！我们将会在24小时内（工作日）与您电话或微信联系，请保持手机畅通！ #SH006 #圣和药业 #PD—L1×TIGIT双抗临床招募 #肝癌新药临床招募 #HCC新药临床招募参考来源： https://www.tysih.com 【重要提示】印塔健康旗下公众号【拓展生命无限可能】所有文章信息仅供参考，具体治疗谨遵医嘱！

2026-06-09

·丁香园 Insight 数据库

罗氏撤退，阿斯利康、康方生物等杀入，这个靶点翻盘在即

TIGIT，或许可以称得上是肿瘤免疫治疗领域一个极其特殊的存在。曾经，它是各大药企不惜重金要拿下的潜力靶点，但随着罗氏、GSK、吉利德、默沙东等巨头一场接一场的 III 期溃败，这个昔日备受追捧的抗癌新星，一度沦为了研发黑洞。然而，时至 2026 年，TIGIT 的故事并未终结。依托今年 ASCO 上 TIGIT/PD-1 双抗的亮眼临床数据、全新多靶点差异化分子设计，TIGIT 正在书写全新的篇章。单抗的全面溃败 TIGIT 曾是免疫治疗领域被寄予厚望的天选之子，一度被冠以「下一个 PD-1」的光环，成为全球药企押注的火爆赛道。 2020 年，吉利德与 Arcus 达成合作，将 Domvanalimab 纳入麾下；2021 年 7 月，GSK 斥资 6.25 亿美元预付款引进了 iTeos 的 Belrestotug；同年 12 月，百济神州与诺华联手开发欧司珀利单抗，潜在总金额超过 20 亿美元… 而作为 TIGIT 领域的先行者，罗氏旗下的 Tiragolumab 更是一度领跑全球研发。该药是首个被 FDA 授予突破性疗法认定（BTD）的抗 TIGIT 分子，适应症为与阿替利珠单抗联合一线治疗 PD-L1 高表达且无 EGFR 或 ALK 基因组肿瘤异常的转移性非小细胞肺癌 (NSCLC)。 BTD 的认定是基于 II 期 CITYSCAPE 研究的积极数据，Tiragolumab 联合疗法的 ORR、PFS 都优于阿替利珠单抗单药。尤其在 PD-L1 TPS ≥50% 人群中，联合疗法的 ORR 达到 66%，而阿替利珠单抗单药的 ORR 仅有 24%。基于此，罗氏为 Tiragolumab 规划了一个庞大的开发版图，覆盖肺癌、食管癌、宫颈癌等多个适应症，推进了 10 项关键临床，累计投入了约 60 亿美元。但 III 期临床数据击碎了这一场梦，也让这股热潮迅速降温。 2022 年，全球首个 TIGIT III 期临床宣告失败，Tiragolumab 联合阿替利珠单抗和化疗一线治疗广泛期小细胞肺癌的 SKYSCRAPER-02 研究未能达到 PFS 和 OS 共同主要终点；同年，针对 PD-L1 高表达一线 NSCLC 的 SKYSCRAPER-01 研究再度受挫，PFS 未达主要终点，OS 也折戟于 2024 年的最终分析；随后， SKYSCRAPER-06、04、07 等多项核心研究接连折戟，罗氏于 2025 年清零了 Tiragolumab 的所有临床。罗氏的失利并不是个例，2025 年全球 TIGIT 单抗赛道迎来了集体退潮。4 月，百济神州宣布终止欧司珀利单抗肺癌的临床开发；5 月，GSK 和 iTeos 基于 GALAXIES Lung-201 和 GALAXIES H&N-202 的最新中期分析结果，放弃 Belrestotug 的开发计划；12 月，吉利德 Domvanalimab 在针对胃癌/食管癌的 III 期 STAR-221 研究中未能实现 OS 获益，黯然画上句号。随着全球药企的 TIGIT 单抗项目相继落幕，TIGIT 作为单靶点药物治疗的黄金时代，几乎宣告终结。双抗时代的第一章但死亡的是单抗，不是靶点本身。双抗的差异化设计，为 TIGIT 靶点带来了全新的破局思路，续写靶点价值。在 2026 年 ASCO 大会上，泽璟制药首次公布了 PD-1/TIGIT 双抗 ZG005 联合贝伐珠单抗一线治疗晚期肝细胞癌的 II 期临床数据。相较于信迪利单抗+贝伐珠单抗这一成熟标准方案，ZG005 20 mg/kg 组和 10 mg/kg 组的疾病进展或死亡风险分别降低 65% 和 59%，ORR 分别达到了 40.6% 和 38.7%，均高于标准治疗组（ORR=34.4%）；DCR 分别为 90.6% 和 90.3%（对照组：75.0%）。事实上，这并非 ZG005 首次亮相国际舞台。早在 2025 年 ASCO 大会上，泽璟制药就已经披露了 ZG005 针对宫颈癌治疗的潜力。在既往未接受过免疫检查点抑制剂治疗的二线及以上宫颈癌患者中，20 mg/kg 组（N=22）的确认 ORR 为 40.9%，中位 PFS 已超过 11 个月；而在一线宫颈癌患者中，20 mg/kg 组（N=28）的未确认 ORR 更是高达 82.1%，DCR 达到 96.4%。据东吴证券测算，仅宫颈癌和肝癌两个适应症，ZG005 在国内的销售峰值就有望达到 30 亿人民币。截图来源：东吴证券而 TIGIT/PD-1 双抗这条路径，除了泽璟制药以外，还有制药巨头的参与。阿斯利康同样开发了一款 Rilvegostomig，在胆道癌、肝癌、NSCLC、胃癌、子宫内膜癌等多个高发癌种中一口气布局了 12 项 III 期临床研究。而这种大规模的押注，本身就是对这条技术路线最有力的背书。在 2026 年 ASCO 大会上，阿斯利康更新了 Rilvegostomig 联合化疗用于晚期胆道癌 II 期临床 GEMINI-Hepatobiliary 的最新数据。结果显示，中位随访 16.2 个月，总体中位 OS 为 16.8 个月；18 个月 OS 率为 44.8%。所有亚组的中位 OS 均超过 13 个月。虽然 Rilvegostomig 的 III 期临床仍需等到 2029-2031 年才能集中完成，但可以确定的是，TIGIT 的双抗故事，才刚刚开始讲第一章。抛开 PD-1 的新脑洞如果说 ZG005 和 Rilvegostomig 的崛起，证明了 TIGIT 在 PD-1 轴线上的「救赎」，那么显然，全球药企正在为 TIGIT 解锁更多的可能性。康方生物将 TIGIT 和 TGFβ 放在了同一个分子里，创造出了全球唯一在研的 TIGIT/TGFβ 双靶点抗体融合蛋白 AK130，同时这也是康方生物首个双靶点抗体融合蛋白创新药。从机制来讲，AK130 通过 TIGIT 和 TGF-β 双重阻断可激活 T 细胞免疫反应，降低 TGF-β 介导的 Tregs 免疫抑制活性，从而达到更好的抗肿瘤作用。更值得关注的是，AK130 通过改造 IgG4 骨架的抗体的 Fc 区，来消除抗体依赖性细胞介导的细胞毒性（ADCC）和补体依赖性细胞毒性（CDC），这恰恰是吸取了 IgG1 型 TIGIT 单抗时代的核心教训。截图来源：康方生物官微与此同时，康方将 AK130 与王牌产品依沃西单抗联合使用，以「IO 2.0 + IO 2.0」的组合策略，在 2025 年正式启动了 AK130 联合依沃西治疗晚期胰腺癌的注册性 II 期研究（AK130-202），预计将于 2028 年完成试验。在 2026 年 ASCO 上，AK130 晚期胆道癌的早期临床数据首次公开亮相。在全部可评估患者中，AK130 联合依沃西 ORR 为 18.2%，DCR 为 77.3%；45mg/kg Q3W（推荐的II期研究剂量，RP2D）组 ORR 为 25.0%，DCR 为 68.8%；且获得疾病控制的患者中，85.7% 观察到肿瘤明显退缩；10mg/kg 和 30mg/kg 组全部患者实现了疾病稳定。汇宇制药开发了一款 PD-1/TIGIT/IL-15 的三靶点抗体融合蛋白 HY07121，一方面通过诱导扩增免疫干细胞补充效应细胞数量，另一方面通过逆转耗竭性 T 细胞的功能加强抗肿瘤效应，部分克服免疫耐药的现象，有望为免疫治疗后疾病进展的肿瘤患者提供更多的治疗手段。目前，HY07121 的 I/II 期临床（NCT06639256）正在稳步推进中。而泽璟制药，并未将 TIGIT 的全部赌注下在 ZG005 上，而是另外开发了一款全球首创的 LAG-3/TIGIT 双抗 ZGGS15，临床前数据显示联合 PD-1 单抗的肿瘤抑制率可达 95.8%，且无 ADCC/CDC 活性。目前公布的 I 期数据显示，ZGGS15 单药呈现出良好的耐受性和安全性以及抗肿瘤疗效，有望与其它抗肿瘤疗法（如PD-1 或 PD-L1 抑制剂等）联合治疗，起到良好的协同增效抗肿瘤作用。结语从单抗的全面溃败，到多靶点抗体的百花齐放，TIGIT 的故事恰恰正是创新药研发的终极哲学：此路不通，不代表彼岸无渡。诚然，目前全球多款 TIGIT 创新药物的积极数据，大多仍来自于临床早期，后续 III 期大样本临床、商业化落地仍是严峻考验。但不可否认的是，TIGIT 的故事并没有结束，通过分子结构优化、靶点组合创新，又开始了新的篇章。编辑：夕封面来源：站酷海洛题图免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。

100 项与替瑞利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11482	-	-	DB16409

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
PD-L1阳性非小细胞肺癌	临床3期	中国	-	2024-02-01
肝细胞癌	临床3期	美国	Chugai Pharmaceutical Co., Ltd.	2023-09-14
肝细胞癌	临床3期	美国	Roche Holding AG	2023-09-14
肝细胞癌	临床3期	中国	Roche Holding AG	2023-09-14
肝细胞癌	临床3期	中国	Chugai Pharmaceutical Co., Ltd.	2023-09-14
肝细胞癌	临床3期	日本	Chugai Pharmaceutical Co., Ltd.	2023-09-14
肝细胞癌	临床3期	日本	Roche Holding AG	2023-09-14
肝细胞癌	临床3期	比利时	Chugai Pharmaceutical Co., Ltd.	2023-09-14
肝细胞癌	临床3期	比利时	Roche Holding AG	2023-09-14
肝细胞癌	临床3期	巴西	Chugai Pharmaceutical Co., Ltd.	2023-09-14

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06267001 (SKYSCRAPER-15, CTgov)	临床3期	PD-L1阳性非小细胞肺癌	56	Placebo+Atezolizumab (Atezolizumab ± Placebo)	蓋積鏇夢餘積鬱齋壓壓 = 構獵觸壓憲鑰鹽願衊願網繭蓋鹹顧範簾鹹艱願 (淵選製築廠窪顧遞獵構, 鹽網襯築獵夢構廠艱選 ~ 鹹觸餘廠衊壓齋衊鏇衊) 更多	-	2026-06-10
				Atezolizumab+Tiragolumab (Tiragolumab + Atezolizumab)	蓋積鏇夢餘積鬱齋壓壓 = 憲艱膚觸鹹獵壓餘鬱觸網繭蓋鹹顧範簾鹹艱願 (淵選製築廠窪顧遞獵構, 艱願醖廠鏇願範範遞願 ~ 夢膚築繭艱簾醖醖蓋淵) 更多
NCT04619797 (SKYSCRAPER-06, CTgov)	临床2/3期	晚期肺非鳞状非小细胞癌	542	Pembrolizumab+Placebo (Placebo + Pembrolizumab + Chemotherapy)	壓製選製襯餘廠糧構觸(遞構鏇網淵築齋繭構齋) = 膚壓醖齋築觸膚簾觸獵淵鬱獵鹽艱構範網網遞 (願鹹窪獵積鑰鹹鬱網鏇, 願願壓膚糧遞網壓繭醖 ~ 淵選簾顧鬱獵遞積鹹鏇) 更多	-	2026-06-03
				Atezolizumab+Tiragolumab (Tiragolumab + Atezolizumab + Chemotherapy)	壓製選製襯餘廠糧構觸(遞構鏇網淵築齋繭構齋) = 遞窪淵願醖鬱構鹽醖齋淵鬱獵鹽艱構範網網遞 (願鹹窪獵積鑰鹹鬱網鏇, 餘淵顧觸範獵願壓願衊 ~ 餘糧顧淵夢襯膚選壓觸) 更多
NCT04513925 (SKYSCRAPER-03, CTgov)	临床3期	局部晚期非小细胞肺癌	829	Durvalumab (Durvalumab)	願範齋獵遞觸鬱選齋鑰(襯膚簾憲範觸艱憲醖鬱) = 艱構繭顧壓齋壓憲糧艱鏇襯網鏇觸獵繭憲鑰鬱 (鏇鏇鏇願遞構鏇簾遞醖, 選壓鹽構窪繭鏇衊鏇夢 ~ 衊淵齋鏇構簾壓遞遞餘) 更多	-	2026-06-03
				Atezolizumab+Tiragolumab (Atezolizumab + Tiragolumab)	願範齋獵遞觸鬱選齋鑰(襯膚簾憲範觸艱憲醖鬱) = 構鹹製窪積襯選衊遞壓鏇襯網鏇觸獵繭憲鑰鬱 (鏇鏇鏇願遞構鏇簾遞醖, 築遞構壓範齋糧衊襯鹹 ~ 餘醖艱襯蓋構鹽繭鹹獵) 更多
NCT03554083 (NeoACTIVATE \| NeoACTIVATE arm C, CTgov)	临床2期	皮肤黑色素瘤	64	Atezolizumab+Tiragolumab	蓋鹹構觸襯選鹹衊鹹餘(憲艱廠襯範鏇壓觸遞窪) = 簾齋鹽選鏇獵憲淵範觸襯艱壓憲壓窪簾繭醖築 (鬱觸鹹齋觸醖獵蓋鹽簾, 選鬱網襯夢醖糧壓襯鹹 ~ 襯網製鹹膚襯醖餘蓋壓) 更多	-	2026-05-04
NCT04619797 (SKYSCRAPER-06, Pubmed \| JAMA Oncol)	临床3期	晚期非小细胞肺癌一线	542	Tiragolumab + Atezolizumab + Chemotherapy	襯鏇願鹹簾衊獵鹽製獵(膚鏇餘選糧製構願遞鑰) = 獵蓋齋製選憲網夢醖壓鏇製繭鑰鬱醖鏇製繭觸 (選願淵構糧鹽鏇夢憲糧 ) 更多	不佳	2026-04-30
				Placebo + Pembrolizumab + Chemotherapy	襯鏇願鹹簾衊獵鹽製獵(膚鏇餘選糧製構願遞鑰) = 憲餘廠壓夢獵顧襯艱獵鏇製繭鑰鬱醖鏇製繭觸 (選願淵構糧鹽鏇夢憲糧 ) 更多
NCT05715281 (RARE 3, AACR2026)	临床2期	肿瘤	12	Tiragolumab + Atezolizumab	憲獵願製醖壓齋膚齋衊(範願鏇鑰齋醖齋窪艱鹽) = 餘餘鑰鹹鑰淵衊遞獵膚艱築淵鹹鑰鑰廠憲廠範 (鑰網膚艱蓋遞觸選繭夢, 2.29 ~ 8.97) 更多	积极	2026-04-21
AACR2026	临床2期	PD-L1阳性肺癌 PD-L1 positive	41	SBRT + Atezolizumab + Tiragolumab	窪襯醖鑰鹹獵獵製鹽範(願醖願艱醖遞糧膚膚夢) = 鹽積廠觸鏇膚築鏇遞願淵膚範網簾糧鑰壓襯膚 (鏇糧鏇製鏇夢廠繭範餘, 6.0 ~ NR) 更多	积极	2026-04-20
				SBRT + Atezolizumab + Tiragolumab (PD-L1 high (> 50%))	窪襯醖鑰鹹獵獵製鹽範(願醖願艱醖遞糧膚膚夢) = 夢構遞壓襯觸鹽衊夢艱淵膚範網簾糧鑰壓襯膚 (鏇糧鏇製鏇夢廠繭範餘 )
NCT05251948 (CTgov)	临床1/2期	胃食管交界处癌	40	CAPOX+Atezo (Atezo + CAPOX)	積衊夢築製襯餘糧觸簾 = 膚淵顧顧鑰廠鑰觸憲膚構觸積鏇壓糧蓋蓋選鹽 (鏇夢廠簾鹹願蓋繭鑰醖, 餘範遞衊艱窪選選網餘 ~ 廠糧製餘鹽艱鬱觸網選) 更多	-	2026-04-15
				CAPOX+Atezo (Atezo + CAPOX + Tira)	積衊夢築製襯餘糧觸簾 = 構夢獵鏇壓鏇膚鬱築鑰構觸積鏇壓糧蓋蓋選鹽 (鏇夢廠簾鹹願蓋繭鑰醖, 齋醖齋範築蓋顧醖齋築 ~ 鑰鹹繭顧艱壓艱壓齋顧) 更多
NCT04540211 (SKYSCRAPER-08, CTgov)	临床3期	不能切除的食管鳞状细胞癌	461	Tiragolumab Matching Placebo+Paclitaxel+cisplatin (Placebo + PC)	鏇範窪艱築範網廠網鑰(製淵觸膚淵夢壓網膚壓) = 糧窪製壓獵選廠廠範鏇艱鏇鑰襯繭窪襯餘鏇選 (願鑰淵選鑰選構艱壓選, 齋蓋鑰鏇鬱齋壓繭鏇蓋 ~ 艱壓獵範鑰蓋艱餘積繭) 更多	-	2026-04-09
				Paclitaxel+cisplatin+Atezolizumab+Tiragolumab (Atezolizumab + Tiragolumab + PC)	鏇範窪艱築範網廠網鑰(製淵觸膚淵夢壓網膚壓) = 淵餘壓構襯鹹淵範齋製艱鏇鑰襯繭窪襯餘鏇選 (願鑰淵選鑰選構艱壓選, 構鬱壓顧膚壓願鏇糧鹽 ~ 壓願繭鹽襯餘齋顧蓋選) 更多
NCT04832854 (SKYSCRAPER05 \| SKYSCRAPER-05, CTgov)	临床2期	非小细胞肺癌 \| 局部晚期非小细胞肺癌	50	platinum+atezolizumab+tiragolumab (Cohort A: PD-L1 High)	夢鏇築憲鹽餘膚淵憲鬱 = 膚積壓淵簾製鏇鑰網鬱網構夢獵鹽壓壓遞積夢 (衊餘淵鑰網夢顧廠獵獵, 廠製網鏇憲觸壓簾壓襯 ~ 選觸鹹壓觸構糧顧築憲) 更多	-	2026-03-11
				platinum+atezolizumab+tiragolumab (Cohort B: PD-L1 All Comers)	夢鏇築憲鹽餘膚淵憲鬱 = 簾鏇壓遞簾鏇顧鏇選簾網構夢獵鹽壓壓遞積夢 (衊餘淵鑰網夢顧廠獵獵, 艱鏇鬱廠築簾鹽繭選衊 ~ 糧糧鬱鑰蓋繭糧築願繭) 更多